Product Overview
The Respiratory Test Kit FlowFlex™ COVID-19 Antigen OTC 300 Tests per Case / 1 Test per Box CLIA Waived is part of ARG Medical's medical supply catalog, manufactured by ACON LABORATORIE.
ARG Medical is a Service-Disabled Veteran-Owned Small Business (SDVOSB) supplying hospitals, VA facilities, and government agencies. Bulk and government pricing available.
Features
- Flowflex Covid-19 Antigen Home test is for use under an FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- Product ships with minimum 30 days dating
- Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection
- This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older
- Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses
- Individuals who test positive should self-isolate and consult their healthcare provider as additional testing may be necessary and for public health reporting
- Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed
- Negative results should be considered in the context of an individual's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19
- Clinical performance showed 93% sensitivity and 100% specificity
Specifications
| Application | Respiratory Test Kit |
| Contents 1 | Case of 300 Boxes, each Box containing: Test Cassette, Disposable Nasal Swab, Extraction Buffer Tube and Package Insert |
| HCPCS | U0002 |
| Number of Tests | 300 Tests per Case / 1 Test per Box |
| Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
| Purchase Program Type | Standard Purchase |
| Reading Type | Visual Read |
| Sample Type | Nasal Swab Sample |
| Specialty | Immunoassay |
| Test Format | Cassette Format |
| Test Kit Type | Rapid |
| Test Method | Lateral Flow Chromatographic Immunoassay |
| Test Name | COVID-19 Antigen OTC |
| Test Type | Antigen Detection |
| Time to Results | 15 Minute Results |
Supplied by the case (CS).
